Transcript VETERINARY DRUG USE AND PRESCRIBING

VETERINARY DRUG USE AND
PRESCRIBING
Chapter 5
Dr. Dipa Brahmbhatt VMD MpH
[email protected]
Brand Name (®) or Not?
– All drugs have 3 names
• Chemical name
• Generic (nonproprietary) name
(active ingredient)
• Trade (proprietary) name
Brand Name (®) or Not?
TRADE NAME:
– Benadryl
CHEMICAL NAME:
– 2(Diphenylmethoxy)-N,N-dimethylethylamine
hydrochloride
CHEMICAL STRUCTURE:
GENERIC NAME:
– diphenhydramine hydrochloride
Brand Name (®) or Not?
CHEMICAL
NAME
NONPROPRIETARY
NAME/
GENERIC NAME
Active ingredient
PROPRIETARY/
TRADE NAME
D(-)-alpha-amino-phydroxybenzyl-penicillin
trihydrate
Amoxicillin
Amoxi-Drop (Pfizer)
Biomox (Virbac)
Robamox-V (FD)
((3-phenoxyphenyl) methyl
cis-trans-3-(2,2dichloroethenyl)-2,2dimethylcyclopropanecarb
oxylate))
Permethrin insecticide
Atroban
Defend
Flysect
Dl 2-(o-chlorophenyl)-2(methylamino)
cyclohexanone
hydrochloride
Ketamine hydrochloride
Ketasat
Vetalar
Chemical Name
– Provides scientific
and technical
information
– Is a precise
description of the
substance
– Example: 7-chloro1,3-dihydro-1methyl-5-phenyl2H-1,4benzodiazepin-2one
Generic Name
Nonpropriety
– Official identifying name of the drug
(assigned by USAN the U.S. Adopted
Names Council)
– Describes the active ingredient
– Written using lowercase letters
– Example: diazepam
Do you know the generic name?
TYLENOL
– acetaminophen
ADVIL
– ibuprofen
CLARITIN
– loratadine
Trade Name
Propriety/ Brand
– Establishes legal proprietary recognition
for the corporation that developed the
drug
– Registered with the U.S. Patent Office,
only by the company that registered the
drug (approved by FDA)
– Written in capital letters or begins with a
capital letter and has a circled, superscript
R (registered) or TM (not registered).
Example: Valium
Xylazine/Rompun®
Trade name?
 Pseudoephedrine
– Sudafed
 Chlorpheniramine
– Chlor-trimeton
 Famotidine
– Pepcid
Generic
Expiry of patent – 17 yrs.
Than other drugs can market drug:
own trademark name or generic
name of drug (trademark law: can’t
look the same)
They must be bioequivalent (produce
similar blood levels as patent)
Can have different pharmacological
effects (vet needs to assess this)
Generic drugs are usually cheaper
Compounding
Is the preparation, mixing assembling,
packaging, and/ or labeling of a drug
based on a prescription drug order
from a licensed practitioner for an
individual patient
Occurs when health professionals
prepare a specialized drug product to
fill an individual patient’s needs when
an approved drug is not available
Suspensions: “Shake Well”
Compounding
 Uses of compounding
– Creating discontinued drugs
(cisapride cats megacolon)
– Creating dosages and strength specific to a patient’s
weight and health
– Creating alternative dose forms such as liquids,
ointments, or chewable tablets (Phenobarb elixir)
– Adding flavoring to drugs to make them more
appealing to animals
– Customizing formulas that combine multiple drugs
for one dose administration
Compounding
 Concerns
– Changes may turn an FDA approved drug
into an unapproved drug
– Compounded drugs are made without FDA
oversight and may pose a risk to the patient
– Compounded drugs may not be sterile
– Errors may result in disease or death in patients
who use them
– Public health concerns
– Food animals: drug residue, withdrawal time,
reaction to drug/inactive forms
Compounding
 1996: Taskforce (vets, pharmacists and regulators):
Compliance Policy Guide (CPG) for FDA-CVM
– discusses that food-producing animals should
not receive drugs that are labeled for humans
 No regulatory action if
– A legitimate medicinal need ID
– Appropriate dose regimen for specific species, size,
age, or medical condition
– No marketed approved animal drug that can treat
condition
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm117042.htm
Sources of Drug Information
 United States Pharmacopoeia (USP)
– Publication that is the legally recognized drug
standard of the United States
– Describes the source, appearance, properties,
standards of purity, and other requirements of the
most important pure drugs
– The FDA requires that all drugs meet USP standards
of purity, quality, and uniformity
• FDA adherence to drug standard and regulation
– All drugs must meet USP standards, be correctly
labeled, identifying the manufacturer and the
directions for use. All advertisements must be true
and correct
Sources of Drug Information
 FDA requires that a drug label state: indications for
use, species to be used in, route of administration,
dose, length of treatment
 Drug label must contain:
– Drug names (generic and trade)
– Drug concentration and quantity
– Name and address of manufacturer
– Manufacturer’s control or lot number
– Expiration date of drug
– Withdrawal time (if warranted)
– Controlled substance status of drug (if
warranted)
Sources of Drug Information
 Package insert
– Provided with drugs to meet regulatory
requirements
• Registered trade name, generic name, controlled
substance notation if warranted
• Description or composition statement
• Clinical pharmacology, actions, or mode of action
• Indications and usage
• Contraindications
• Precautions
• Warnings
• Adverse reactions or side effects
• Overdosage information
• Dosage administration
• Storage
• How supplied
Sources of Drug Information
 Drug References
– Bound book of information on package inserts
• Physician’s Desk Reference (PDR): human-approved
drugs. Plumbs veterinary Drug book
• Veterinary Pharmaceuticals and Biologicals (VPB)
• Compendium of Veterinary Products (CVP)
Expiration Dates
 The date before which a
drug meets all
specifications and after
which the drug can no
longer be used
 Based on the stability of
or experience with the
drug
 Drugs that are mixed in
the clinic vary depending
on the reconstitution and
refrigeration status of the
drugs
Dispensing vs. Prescribing
 Veterinary drugs are those approved only
for use in animals
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Certain indication
Certain species
Certain route of administration
Certain dose
Certain length of time
 Human drugs are approved by the FDA, in
food-producing animals: CPG
Prescription
 Veterinary prescription drugs are labeled for use
only by or on the order of a licensed veterinarian
 Veterinary prescription drugs must be properly
labeled before being dispensed
 A veterinary/client/patient relationship (VCPR)
exists
 Dispensing and treatment records must be
maintained
 Drugs should be dispensed only in quantities
required for the treatment of the animals
VCPR
Abbreviation for documentation
Abbreviation for documentation
Prescriptions
 A prescription is an
order to a pharmacist,
written by a licensed
veterinarian, to
prepare the prescribed
medicine, to affix the
directions, and to sell
the preparation to the
client
The Prescription
1. The name and address of the
dispenser
• Controlled substances, need
DEA #
2. The client’s name and address,
patient: species, name
3. The drug name, strength, and
quantity
The Prescription
4. Sig: Instructions
– Amount to be given
– Administration route/ frequency and
duration
5. # refills permitted
6. Veterinarian's signature
7. Date of prescription
NB: +/- cautionary statement
Prescription
Label on the Prescription
The label on the prescription should be
complete and contain:
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The name and address of the dispenser
The client’s name (+/- address)
The animal’s name and species
The drug name, strength, and quantity
The date of the order
Directions for use
Any refill information (if warranted)
DRUG LABEL ON PRESCRIPTION BOTTLE
Dispensing Drugs
Prescription drugs may be dispensed by
pharmacists / trained veterinary staff
Veterinary prescription drugs should be
properly labeled when dispensed
Veterinary staff members cannot refill or
dispense medications without vet approval
Medications dispensed in childproof
containers
Expiry date
Light sensitive: Amber colored bottles
Write a zero before any decimal point
Electronic and Paperless Record Keeping
Vets write the medication order in a paper
file or type it into an electronic record
Medical record with the date, time, and
the initials of the person giving the drug
Vets using completely paperless electronic
medical record system is increasing
Electronic and Paperless Record Keeping
– Avoidance of errors
• Prompts for patients
with allergic reactions
• Information on drug
interactions
• Identification of clients
with special
considerations
– Automated input
• Laboratory data
automatically transfers
into patient record
• Prescription
instructions can be
entered into the
computer in advance
Pharmacy Economics
Inventory and Control Maintenance
– Time invested in maintenance of appropriate stock
levels benefits the overall business health of the
veterinary practice
– The goal is to stock quantities of each item as low as
possible to reduce overhead and inventory costs, but
now low enough to have a shortage
– The longer inventory sits on the shelf: hidden costs
– Too much inventory ties up money
– 80/20 rule: 20% drugs stocked , 80% of annual exp.
Turnover rate = Yearly inventory expense/ Avg. cost of
inventory on hand
 4 (drug replaced 4 times/year)
 Goal: 12
Pharmacy Economics
 Inventory Purchasing
– Direct marketing is when a drug is purchased
directly from the company that manufacturers it
– Distributors or wholesalers are agencies that
purchase the drug from the manufacturers and resell
it to the veterinarians
– Generic drugs: Submit Abbreviated New Drug
Application (ANAD)
– Other sources of drugs include veterinary practices,
buying groups of several veterinary practices, and
pharmacies
Pharmacy Economics
 Inventory Management
– Managing pharmaceuticals includes
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Maintaining an adequate stock
Organizing so items are easy to locate
Identifying products that need to be reordered
Receiving and inspecting shipments
Rotating stock and monitoring expiration dates